Balloon catheter

Abstract

The balloon catheter comprises a balloon assembly and a limiting assembly, the balloon assembly comprises a main body section, a near-end connecting section and a far-end connecting section, the near-end connecting section is connected to the near end of the main body section, the far-end connecting section is connected to the far end of the main body section, and when the balloon assembly is in an expansion state, the diameter of the main body section is gradually reduced from the near end to the far end; the limiting assembly wraps the outer side of the balloon assembly, the limiting assembly is provided with a plurality of meshes, and the limiting assembly is used for exerting radial pressing and gripping force on the balloon assembly when the balloon assembly is in an expansion state, so that the main body section protrudes outwards at the positions corresponding to the meshes to form protruding parts, and the protruding parts protrude outwards in the axial direction of the balloon assembly. The diameter of the position corresponding to the protruding part close to the far-end connecting section is smaller than that of the position corresponding to the protruding part far away from the far-end connecting section. According to the balloon catheter, the probability that the far end of a lesion blood vessel is torn to generate an interlayer can be reduced.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a balloon catheter. Background Art

[0002] Lower extremity arterial stenosis or occlusion is a common manifestation of lower extremity arteriosclerosis obliterans. The core of treatment for lower extremity arteriosclerosis obliterans is restoring blood flow to improve distal blood supply. Traditional treatments include surgical bypass surgery and endovascular interventions. Balloon dilation, as the foundation of endovascular interventions, has undergone iterative upgrades from standard balloons to specialized balloons and has gradually become the mainstream option. Lower extremity arteriosclerosis often presents as long lesions with tapered vessels, which presents multiple challenges for balloon dilation. Standard balloons have a uniform diameter and are difficult to adapt to tapered vessels. Choosing a balloon that fits proximally can lead to distal over-dilation and increase the risk of perforation, while choosing a balloon that fits distally can result in proximal under-dilation and poor efficacy. When the balloon dilates small distal vessels, the shear force generated by the deployment of the balloon wings is unevenly distributed, potentially leading to residual stenosis or significant elastic recoil, compromising long-term patency. Distal intimal tears and vessel rupture are more likely to occur. Post-dilation blood flow restoration in long lesions is suboptimal, making dissection or thrombosis more likely. Summary of the Invention

[0003] Based on this, a balloon catheter is provided to solve the problem of tearing and dissection at the distal end of the diseased blood vessel.

[0004] The present application provides a balloon catheter, comprising:

[0005] The balloon assembly comprises a main body segment, a proximal connecting segment, and a distal connecting segment, wherein the proximal connecting segment is connected to the proximal end of the main body segment, and the distal connecting segment is connected to the distal end of the main body segment. When the balloon assembly is in an expanded state, the diameter of the main body segment gradually decreases from the proximal end to the distal end.

[0006] A restriction component is coated on the outside of the balloon component, and the restriction component has a plurality of meshes. The restriction component is used to apply a radial compressive force to the balloon component when the balloon component is in an expanded state, so that the main body segment bulges outward at positions corresponding to the plurality of meshes to form a protrusion. Along the axial direction of the balloon component, the diameter of the position corresponding to the protrusion closer to the distal connecting segment is smaller than the diameter of the position corresponding to the protrusion farther from the distal connecting segment.

[0007] In one embodiment, when the balloon assembly is in an expanded state, the number of the protrusions formed on the proximal circumference of the balloon catheter is greater than or equal to the number of the protrusions formed on the distal circumference;

[0008] Alternatively, when the balloon assembly is in an expanded state, the surface area of ​​the protrusion formed on the proximal circumference of the balloon catheter is greater than or equal to the surface area of ​​the protrusion formed on the distal circumference;

[0009] Alternatively, when the balloon assembly is in an expanded state, a protrusion formed on the proximal circumference of the balloon catheter has a height greater than or equal to a protrusion formed on the distal circumference from the corresponding mesh.

[0010] In one embodiment, the material of the restriction component is a shape memory metal material;

[0011] And / or, the restriction assembly has a compressed state and an expanded state, and can be switched from the compressed state to the expanded state when the balloon assembly is inflated, and can be switched from the expanded state to the compressed state when the balloon assembly is depressurized.

[0012] In one embodiment, the restriction assembly has an expanded position, and in the expanded position, the portion of the restriction assembly corresponding to the main segment has the same taper as the main segment of the balloon assembly, and when the balloon assembly is expanded, the restriction assembly remains in the expanded position.

[0013] In one embodiment, the proximal end of the restriction component is connected to the proximal connecting segment, and the distal end of the restriction component is connected to the distal connecting segment. The restriction component includes a telescopic segment, which covers the entire main body segment. When the balloon component is expanded, the telescopic segment can expand as the diameter of the main body segment expands and form a plurality of meshes.

[0014] In one embodiment, the telescopic section includes multiple first connecting wires and multiple second connecting wires, the multiple first connecting wires are arranged at intervals in the circumferential direction of the balloon component, and the multiple second connecting wires are arranged around the circumferential side of the balloon component, and the multiple first connecting wires and the multiple second connecting wires cross each other to form a plurality of the meshes.

[0015] In one embodiment, the first connecting wire includes a first section and a second section, the first section is arranged along the axial direction of the telescopic section, the second section is connected to the distal end of the first section, and the second section is spirally wound around the central axis of the telescopic section, wherein the length of the second section in the axial direction corresponding to the telescopic section is greater than or equal to 1 / 2 of the axial length of the telescopic section.

[0016] In one embodiment, the diameter of the first connecting wire gradually decreases from the proximal end to the distal end, and the diameter of the first connecting wire at the proximal end is 0.5 mm to 6 mm, and the diameter of the first connecting wire at the distal end is 0.2 mm to 4 mm.

[0017] In one embodiment, along the axial direction of the telescopic section, the diameter of the second connecting wire closer to the distal end is smaller than the diameter of the second connecting wire farther from the distal end.

[0018] In one embodiment, the diameter of the second connecting wire closest to the distal end of the telescopic section is 0.2 mm to 4 mm, and the diameter of the second connecting wire farthest from the distal end of the telescopic section is 0.5 mm to 6 mm.

[0019] In one embodiment, at a position corresponding to the same mesh hole, the diameter of the first connecting wire is smaller than or equal to the diameter of the second connecting wire.

[0020] In one embodiment, the balloon catheter further comprises a catheter assembly, both ends of the balloon assembly and both ends of the restriction assembly are connected to the catheter assembly, and the catheter assembly is used to inflate and deflate the balloon assembly.

[0021] In one embodiment, the proximal connecting section includes a first cone and a first connecting section, the first cone is connected between the main section and the first connecting section, the limiting assembly includes a first supporting section and a first fixing section, the first supporting section is connected between the first fixing section and the telescopic section, the first supporting section is conical and corresponds to the first cone, the first fixing section is sleeved on the outside of the first connecting section, and fixes the first connecting section to the catheter assembly;

[0022] And / or, the distal connecting section includes a second cone and a second connecting section, the second cone is connected between the main section and the second connecting section, the limiting assembly includes a second supporting section and a second fixed section, the second supporting section is connected between the second fixed section and the telescopic section, the second supporting section is conical and corresponds to the second cone, the second fixed section is sleeved on the outside of the second connecting section, and fixes the second connecting section to the catheter assembly.

[0023] The above-mentioned balloon catheter includes a balloon component and a restriction component, and the restriction component is covered on the outside of the balloon component. Since the restriction component has multiple meshes, when the balloon component is in an expanded state, the restriction component applies a radial compressive force to the balloon component, so that part of the structure of the balloon component bulges from the mesh to form a protrusion. Since the diameter of the position corresponding to the protrusion closer to the distal connecting section along the axial direction of the balloon component is smaller than the diameter of the position corresponding to the protrusion farther from the distal connecting section, when the balloon catheter is implanted in a diseased blood vessel, the expansion degree is greater in the area with a larger proximal diameter and smaller in the area with a smaller distal diameter, so as to reduce the probability of tearing and dissection at the distal end of the diseased blood vessel. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 This is a schematic structural diagram of a balloon assembly of a balloon catheter according to one embodiment when it is in an expanded state.

[0025] Figure 2 This is a schematic diagram of the combined structure of the balloon component and the restriction component in a balloon catheter according to one embodiment when the balloon component is in an expanded state.

[0026] Figure 3 This is a schematic diagram of the combined structure of the balloon component and the restriction component in a balloon catheter according to another embodiment when the balloon component is in an expanded state.

[0027] Figure 4 This is a schematic diagram of the combined structure of the balloon component and the restriction component in a balloon catheter according to another embodiment when the balloon component is in an expanded state.

[0028] Figure 5 Schematic diagram of the structure of a balloon catheter according to one embodiment.

[0029] Description of Figure Numbers:

[0030] 10. Balloon assembly; 10a. Protrusion; 11. Main body section; 12. Proximal connecting section; 121. First cone; 122. First connecting section; 13. Distal connecting section; 131. Second cone; 132. Second connecting section; 20. Limiting assembly; 20a. Mesh; 21. Telescopic section; 211. First connecting wire; 2111. First section; 2112. Second section; 212. Second connecting wire; 22. First supporting section; 23. First fixing section; 24. Second supporting section; 25. Second fixing section; 30. Catheter assembly. DETAILED DESCRIPTION

[0031] To make the above-mentioned objects, features, and advantages of the present application more clearly understood, the specific embodiments of the present application are described in detail below with reference to the accompanying drawings. The following description sets forth many specific details to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways than those described herein, and those skilled in the art can make similar improvements without violating the scope of the present application. Therefore, the present application is not limited to the specific embodiments disclosed below.

[0032] It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be an intermediate element. When an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be an intermediate element.

[0033] It should be noted that the terms "distal" and "proximal" are commonly used in the field of interventional medical devices. "Distal" refers to the end away from the operator (e.g., physician) during surgery, while "proximal" refers to the end closer to the operator. Axial refers to the direction along which the central axis of the medical device extends, while radial refers to the direction perpendicular to the axial direction.

[0034] Combine Figure 1 As shown, Figure 1 The structure of the balloon assembly 10 when in an expanded state is shown. A balloon catheter includes the balloon assembly 10. An embodiment of the present application provides a balloon catheter, wherein the balloon assembly 10 includes a main body section 11, a proximal connecting section 12, and a distal connecting section 13. The proximal connecting section 12 is connected to the proximal end of the main body section 11, and the distal connecting section 13 is connected to the distal end of the main body section 11. When the balloon assembly 10 is in an expanded state, the diameter of the main body section 11 gradually decreases from the proximal end to the distal end, so that the main body section 11 is tapered as a whole, which facilitates supporting the vascular wall of a diseased blood vessel with a tapered change.

[0035] The inventors have discovered that while the diameter of the main body segment 11 gradually decreases from the proximal end to the distal end, allowing the balloon assembly 10 to better conform to tapered lesions and better fit the vascular anatomy, reducing over-expansion or under-expansion, and lowering the risk of distal perforation and dissection, for vessels with long lesions, the difference in diameter between the distal and proximal ends of the main body segment 11 can easily lead to excessive expansion of the distal end of the vessel, which can cause tearing and dissection.

[0036] Combine Figure 2 As shown, Figure 2The balloon catheter of the embodiment of the present application further includes a restriction assembly 20. The restriction assembly 20 is coated on the outside of the balloon assembly 10. The restriction assembly 20 has a plurality of meshes 20a. The restriction assembly 20 is configured to apply a radial compressive force to the balloon assembly 10 when the balloon assembly 10 is in an expanded state, causing the main body 11 to bulge outward at locations corresponding to the plurality of meshes 20a to form protrusions 10a. Along the axial direction of the balloon assembly 10, the diameter of the protrusions 10a located closer to the distal connecting segment 13 is smaller than the diameter of the protrusions 10a located farther from the distal connecting segment 13.

[0037] It should be noted that the balloon catheter is implanted into the diseased vessel with the balloon assembly 10 in a deflated state. After implantation, the balloon assembly 10 is expanded by inflating it. Because the outer surface of the balloon assembly 10 is coated with the restriction assembly 20, after the balloon assembly 10 has expanded to a certain extent, the portion of the balloon assembly 10 constrained by the restriction assembly 20 (i.e., the portion of the balloon assembly 10 that abuts against the structure of the restriction assembly 20 that encloses the mesh 20a) will no longer expand. However, the portion of the balloon assembly 10 not constrained by the restriction assembly 20 (i.e., the portion of the balloon assembly 10 corresponding to the mesh 20a) will bulge outward from the corresponding mesh 20a as the balloon is inflated, forming a protrusion.

[0038] When these protrusions support the vessel wall, protrusions 10a at different axial locations on the main body section 11 exert varying compressive forces on the plate on the vessel wall, causing the vessel to expand to varying degrees at different axial locations. Because the diameter of protrusions 10a located closer to the distal connecting section 13 is smaller than that of protrusions 10a located farther from the distal connecting section 13, the protrusions located in the distal region exert less expansion on the vessel than those located in the proximal region, thereby reducing the risk of tearing and dissection at the distal end of the vessel.

[0039] It should be noted that the size of the mesh 20a corresponding to the limiting component 20 can be set to different, or the limiting component 20 can apply different gripping forces to different axial positions of the main segment 11, so that protrusions 10a of different sizes are formed at different axial positions of the main segment 11, which is conducive to applying different squeezing forces on the plaque on the blood vessel wall.

[0040] For example, in some embodiments, when the balloon assembly 10 is in an expanded state, the number of protrusions 10a formed on the proximal circumference of the balloon catheter is greater than or equal to the number of protrusions 10a formed on the distal circumference. For another example, when the balloon assembly 10 is in an expanded state, the surface area of ​​the protrusions 10a formed on the proximal circumference of the balloon catheter is greater than or equal to the surface area of ​​the protrusions 10a formed on the distal circumference. In other embodiments, when the balloon assembly 10 is in an expanded state, the height of the protrusions 10a formed on the proximal circumference of the balloon catheter from the corresponding mesh 20a is greater than or equal to the height of the protrusions 10a formed on the distal circumference from the corresponding mesh 20a.

[0041] In some embodiments, the restraint assembly 20 is made of a shape-memory metal material. Thus, the restraint assembly 20 can maintain a memorized shape, thereby facilitating consistent crimping when crimping the balloon assembly 10. Shape-memory metal materials include, but are not limited to, nickel-titanium alloys, copper-based alloys (such as Cu-Zn-Al or Cu-Al-Ni), or iron-based alloys (such as Fe-Mn-Si).

[0042] In some embodiments, the restriction assembly 20 has a compressed state and an expanded state, and can switch from the compressed state to the expanded state when the balloon assembly 10 is inflated, and from the expanded state to the compressed state when the balloon assembly 10 is depressurized. Thus, when the balloon assembly 10 is in the depressurized state, the restriction assembly 20 is in the compressed state, so that both the balloon assembly 10 and the restriction assembly 20 have a smaller diameter. In this case, after the restriction assembly 20 is wrapped around the balloon assembly 10, it can be conveniently loaded into a delivery sheath, such as a delivery sheath, for delivery to a suitable location within the diseased vessel and release. It should be noted that after the balloon assembly 10 and the restriction assembly 20 are released together into the diseased vessel, the balloon assembly 10 can be inflated, causing the balloon assembly 10 to expand and simultaneously drive the restriction assembly 20 to radially expand, thereby switching the restriction assembly 20 from the compressed state to the expanded state. Therefore, in this embodiment, by configuring the restriction assembly 20 to expand and contract with the inflation and depressurization of the balloon assembly 10, the ease of implantation and subsequent support of the vessel wall can be improved.

[0043] It should be noted that the restriction assembly 20 has an expanded position, and in this expanded position, the portion of the restriction assembly 20 corresponding to the main body section 11 has the same taper as the main body section 11 of the balloon assembly 10. When the balloon assembly 10 expands, the restriction assembly 20 remains in the expanded position. Thus, as the balloon assembly 10 continues to inflate, the restriction assembly 20 no longer expands. Consequently, the restriction assembly 20 maintains the same taper as the main body section 11 of the balloon assembly 10, allowing the restriction assembly 20 to exert a uniform pressure and grip on the balloon assembly 10, thereby facilitating the balloon assembly 10 to stably bulge outward at locations corresponding to the plurality of meshes 20a, thereby enhancing the stability of the protrusion 10a and facilitating support at corresponding locations on the blood vessel wall.

[0044] Continue to combine Figure 2 As shown, the proximal end of the restriction component 20 is connected to the proximal connecting section 12. The distal end of the restriction component 20 is connected to the distal connecting section 13. The restriction component 20 includes a telescopic section 21, which covers the entire main section 11. When the balloon component 10 expands, the telescopic section 21 can expand as the diameter of the main section 11 expands and form a plurality of meshes 20a. In this embodiment, the restriction component 20 forms the meshes 20a by setting the telescopic section 21, so that the restriction component 20 can not only be conveniently maintained in a compressed state with the balloon component 10 in a depressurized state to facilitate transportation; at the same time, it is also beneficial that during the inflation process of the balloon component 10, the diameter expansion of the main section 11 will drive the telescopic section 21 to expand and form a plurality of meshes 20a, so that the balloon component 10 will eventually bulge outward at the position corresponding to the plurality of meshes 20a to form a protrusion 10a.

[0045] In some embodiments, the telescopic section 21 includes a plurality of first connecting wires 211 and a plurality of second connecting wires 212. The plurality of first connecting wires 211 are spaced apart circumferentially around the balloon assembly 10, and the plurality of second connecting wires 212 are disposed around the circumference of the balloon assembly 10. The plurality of first connecting wires 211 and the plurality of second connecting wires 212 intersect with each other to form a plurality of meshes 20a. In this embodiment, since the meshes 20a are formed by the intersecting arrangement of the first connecting wires 211 and the second connecting wires 212, the enclosed meshes 20a are stable, thereby facilitating a stable protrusion 10a.

[0046] It should be noted that, in some embodiments, the number of first connecting wires 211 can be 4 to 7, for example, 4, 5, 6, or 7. The number of second connecting wires 212 can be 5 to 8, for example, 5, 6, 7, or 8. The number of first connecting wires 211 and second connecting wires 212 is not limited herein. The number of protrusions 10a can be set specifically according to the desired shape and size of the protrusions 10a.

[0047] like Figure 2 As shown, the first connecting wire 211 can extend from the proximal end to the distal end of the telescopic section 21, that is, each first connecting wire 211 on the telescopic section 21 extends from the proximal end to the distal end of the telescopic section 21. Under this structure, the overall tensile strength of the first connecting wire 211 is good, which is conducive to dividing the balloon assembly 10 into multiple uniform parts in the circumferential direction around the main body section 11 through multiple first connecting wires 211, thereby making the number of protrusions 10a at different axial positions of the balloon assembly 10 consistent. For example, the telescopic section 21 includes 5 first connecting wires 211, and the 5 first connecting wires 211 all extend from the proximal end to the distal end of the telescopic section 21, so that at different axial positions of the corresponding balloon assembly 10, there will be 5 protrusions 10a separated by the 5 first connecting wires 211.

[0048] Combine Figure 3 As shown, the first connecting wire 211 may not extend from the proximal end to the distal end of the telescopic section 21. In some embodiments, the number of first connecting wires 211 between any adjacent second connecting wires 212 is different. Thus, at different axial positions of the corresponding telescopic section 21, the number of meshes 20a enclosed by the first connecting wires 211 and the second connecting wires 212 is different. Accordingly, the number of protrusions 10a formed by the balloon assembly 10 corresponding to the meshes 20a bulging outward is different. For example, in some embodiments, the number of first connecting wires 211 located at the proximal end of the telescopic section 21 is 8, and the 8 first connecting wires 211 divide 8 meshes 20a between 2 adjacent second connecting wires 212, so that the meshes 20a of the balloon assembly 10 at the proximal end position of the corresponding telescopic section 21 bulge outward to form 8 protrusions. For another example, if the number of the first connecting wires 211 located at the distal end of the telescopic section 21 is 5, the 5 first connecting wires 211 divide 5 meshes 20a between 2 adjacent second connecting wires 212, so that the meshes 20a of the balloon assembly 10 at the distal end position corresponding to the telescopic section 21 bulge outward to form 5 protrusions.

[0049] Combine Figure 4 As shown, in some embodiments, the first connecting wire 211 includes a first section 2111 and a second section 2112. The first section 2111 is arranged along the axial direction of the telescopic section 21, and the second section 2112 is connected to the distal end of the first section 2111. The second section 2112 is spirally wound around the central axis of the telescopic section 21, wherein the length of the second section 2112 in the axial direction of the corresponding telescopic section 21 is greater than or equal to 1 / 2 of the axial length of the telescopic section 21.

[0050] It should be noted that because the second section 2112 is spirally coiled, the mesh 20a corresponding to the second section 2112 is roughly diamond-shaped when the balloon assembly 10 is inflated. This makes the distal end of the balloon catheter more flexible and easier to pass through stenotic lesions, thereby minimizing damage to the stenotic blood vessels. Because the first section 2111 near the proximal end of the telescopic section 21 extends roughly along the central axis of the telescopic section 21, when the balloon is inflated, the mesh 20a corresponding to the first section 2111 is roughly square-shaped, facilitating the provision of strong support along the axial direction of the telescopic section 21, thereby enhancing the axial pushability of the proximal end of the balloon catheter and preventing balloon stacking.

[0051] In some embodiments, the diameter of the first connecting wire 211 gradually decreases from the proximal end to the distal end, and the diameter of the proximal end of the first connecting wire 211 is 0.5mm to 6mm, and the diameter of the distal end of the first connecting wire 211 is 0.2mm to 4mm. In this way, since the thinner the diameter of the first connecting wire 211, the better the flexibility, correspondingly, the thicker the diameter of the first connecting wire 211, the better its axial support performance. Therefore, in this embodiment, the diameter of the first connecting wire 211 is set to decrease from the proximal end to the distal end component, so that the distal end of the limiting component 20 has good flexibility, which is conducive to passing through the stenotic lesions and avoiding damage to the blood vessels at the stenosis. At the same time, the proximal end of the limiting component 20 can have sufficient supporting force to facilitate enhancing the axial pushability of the proximal end position of the balloon catheter to avoid balloon stacking.

[0052] In some embodiments, along the axial direction of the telescopic section 21, the diameter of the second connecting wire 212 closer to the distal end is smaller than the diameter of the second connecting wire 212 farther from the distal end. Since the second connecting wire 212 is arranged around the circumference of the balloon assembly 10, the thinner the second connecting wire 212, the easier it is for the corresponding position to contract, and the corresponding radial outward expansion force is smaller. Subsequently, with this structural arrangement of this embodiment, the distal end of the telescopic section 21 is easily deformed by compression in the radial direction. In other words, the expansion force of the distal end of the telescopic section 21 on the blood vessel wall is small, and thus it is not easy to tear the distal end of the blood vessel and cause a dissection. Accordingly, the proximal end of the telescopic section 21 is not easily deformed by compression in the radial direction. In other words, the expansion force of the proximal end of the telescopic section 21 on the blood vessel wall is large, which is conducive to improving the supporting force of the protrusion 10a at the corresponding position on the proximal end of the blood vessel wall.

[0053] In some embodiments, the diameter of the second connecting wire 212 closest to the distal end of the telescopic section 21 is 0.2 mm to 4 mm, for example, 0.2 mm, 0.3 mm, 0.9 mm, 1.3 mm, 2.5 mm, 3.3 mm, or 4 mm. The diameter of the second connecting wire 212 farthest from the distal end of the telescopic section 21 is 0.5 mm to 6 mm, for example, 0.5 mm, 1.3 mm, 2.9 mm, 3.3 mm, 4.5 mm, 5.3 mm, or 6 mm. In this embodiment, by properly setting the diameters of the second connecting wire 212 at the distal and proximal ends of the telescopic section 21, the distal end of the telescopic section 21 is easily contracted, thereby reducing the expansion force on the blood vessel wall, while the proximal end of the telescopic section 21 can maintain a sufficiently large expansion force, thereby improving the stability of the protrusion 10a near the proximal end.

[0054] It should be noted that the diameters of the first connecting wire 211 and the second connecting wire 212 can be the same or different, and this is not limited here. For example, in some embodiments, at locations corresponding to the same mesh 20a, the diameter of the first connecting wire 211 is less than or equal to the diameter of the second connecting wire 212. This allows the restriction assembly 20 to have good axial flexibility to facilitate passage through narrow areas. At the same time, the restriction assembly 20 provides stable support in the radial direction to help maintain the stability of the protrusion 10a.

[0055] Combine Figure 5 As shown, in some embodiments, the balloon catheter further includes a catheter assembly 30, both ends of the balloon assembly 10 and both ends of the restriction assembly 20 are connected to the catheter assembly 30, and the catheter assembly 30 is used to inflate and deflate the balloon assembly 10. In this embodiment, the catheter assembly 30 is used to inflate and deflate the balloon assembly 10 to meet the use requirements of the balloon catheter. For example, before the balloon catheter is implanted into a blood vessel, the balloon assembly 10 can be maintained in a contracted state. After the balloon assembly 10 is released to a suitable position in the blood vessel using a delivery structure such as a delivery sheath, the balloon assembly 10 is inflated through the catheter assembly 30, so that the balloon assembly 10 bulges outward at the multiple meshes 20a corresponding to the restriction assembly 20 to form a protrusion 10a. The multiple protrusions 10a are used to apply a suitable squeezing force to the blood spots on the blood vessel wall, thereby facilitating the stability of the balloon assembly 10 in the blood vessel and reducing the probability of tearing and forming a dissection at the distal end of the blood vessel.

[0056] In some embodiments, the proximal connecting section 12 includes a first cone 121 and a first connecting section 122, the first cone 121 is connected between the main section 11 and the first connecting section 122, the limiting assembly 20 includes a first supporting section 22 and a first fixed section 23, the first supporting section 22 is connected between the first fixed section 23 and the telescopic section 21, the first supporting section 22 is conical and corresponds to the first cone 121, the first fixed section 23 is sleeved on the outside of the first connecting section 122, and fixes the first connecting section 122 to the catheter assembly 30.

[0057] In some embodiments, the distal connecting section 13 includes a second cone 131 and a second connecting section 132, the second cone 131 is connected between the main section 11 and the second connecting section 132, the limiting assembly 20 includes a second supporting section 24 and a second fixed section 25, the second supporting section 24 is connected between the second fixed section 25 and the telescopic section 21, the second supporting section 24 is conical and corresponds to the second cone 131, the second fixed section 25 is sleeved on the outside of the second connecting section 132, and fixes the second connecting section 132 to the catheter assembly 30.

[0058] In some embodiments, the catheter assembly 30 comprises an outer tube, an inner tube, and a connector. The outer tube may be a three-layer composite structure. In some embodiments, the middle layer of the outer tube is braided from circular stainless steel, with a variable-density braid pattern that gradually decreases in density from distal to proximal, with a PPI ranging from 70 to 35. The outer tube increases in rigidity from distal to proximal. This allows for a more flexible distal end to facilitate traversal and tortuous lesions, while the proximal end is more rigid for easier insertion.

[0059] The technical features of the above embodiments can be combined arbitrarily. To make the description concise, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0060] The above embodiments merely illustrate several implementation methods of the present application, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the present invention. It should be noted that a person skilled in the art would be able to make various modifications and improvements without departing from the inventive concept of the present application, all of which fall within the scope of protection of the present application. Therefore, the scope of protection of the present invention shall be determined by the appended claims.

Claims

1. A balloon catheter, characterized in that: include: A balloon assembly (10) comprises a main body segment (11), a proximal connecting segment (12) and a distal connecting segment (13), wherein the proximal connecting segment (12) is connected to the proximal end of the main body segment (11), and the distal connecting segment (13) is connected to the distal end of the main body segment (11); when the balloon assembly (10) is in an expanded state, the diameter of the main body segment (11) gradually decreases from the proximal end to the distal end; A limiting component (20) is coated on the outside of the balloon component (10), and the limiting component (20) has a plurality of meshes (20a). The limiting component (20) is used to apply a radial compressive force to the balloon component (10) when the balloon component (10) is in an expanded state, so that the main body section (11) bulges outward at positions corresponding to the plurality of meshes (20a) to form a protrusion (10a). Along the axial direction of the balloon component (10), the diameter of the position corresponding to the protrusion (10a) closer to the distal connecting section (13) is smaller than the diameter of the position corresponding to the protrusion (10a) farther from the distal connecting section (13).

2. The balloon catheter according to claim 1, characterized in that When the balloon assembly (10) is in an expanded state, the number of the protrusions (10a) formed on the proximal circumference of the balloon catheter is greater than or equal to the number of the protrusions (10a) formed on the distal circumference; Alternatively, when the balloon assembly (10) is in an expanded state, the surface area of ​​the protrusion (10a) formed on the proximal circumference of the balloon catheter is greater than or equal to the surface area of ​​the protrusion (10a) formed on the distal circumference; Alternatively, when the balloon assembly (10) is in an expanded state, the protrusion (10a) formed on the proximal circumference of the balloon catheter has a protrusion height from the corresponding mesh (20a) greater than or equal to the protrusion height from the corresponding mesh (20a) formed on the distal circumference.

3. The balloon catheter according to claim 1 or 2, characterized in that: The material of the limiting component (20) is a shape memory metal material; And / or, the restriction component (20) has a compressed state and an expanded state, and is capable of switching from the compressed state to the expanded state when the balloon component (10) is inflated, and switching from the expanded state to the compressed state when the balloon component (10) is depressurized.

4. The balloon catheter according to claim 1 or 2, characterized in that: The restriction component (20) has an expanded position, and in the expanded position, the portion of the restriction component (20) corresponding to the main body section (11) has the same taper as the main body section (11) of the balloon component (10), and when the balloon component (10) is expanded, the restriction component (20) remains in the expanded position.

5. The balloon catheter according to claim 1 or 2, characterized in that: The proximal end of the restriction component (20) is connected to the proximal connecting section (12), and the distal end of the restriction component (20) is connected to the distal connecting section (13). The restriction component (20) includes a telescopic section (21), and the telescopic section (21) covers the entire main section (11). When the balloon component (10) is expanded, the telescopic section (21) can be expanded along with the diameter expansion of the main section (11) to form a plurality of meshes (20a). The balloon catheter according to claim 5 , wherein: The telescopic section (21) includes a plurality of first connecting wires (211) and a plurality of second connecting wires (212), wherein the plurality of first connecting wires (211) are arranged at intervals in the circumferential direction of the balloon component (10), and the plurality of second connecting wires (212) are arranged around the circumference of the balloon component (10), and the plurality of first connecting wires (211) and the plurality of second connecting wires (212) cross each other to form a plurality of meshes (20a).

7. The balloon catheter according to claim 6, characterized in that The first connecting wire (211) includes a first section (2111) and a second section (2112), wherein the first section (2111) is arranged along the axial direction of the telescopic section (21), and the second section (2112) is connected to the distal end of the first section (2111), and the second section (2112) is spirally wound around the central axis of the telescopic section (21), wherein the length of the second section (2112) in the axial direction corresponding to the telescopic section (21) is greater than or equal to 1 / 2 of the axial length of the telescopic section (21).

8. The balloon catheter according to claim 6, characterized in that The diameter of the first connecting wire (211) gradually decreases from the proximal end to the distal end, and the diameter of the first connecting wire (211) at the proximal end is 0.5 mm to 6 mm, and the diameter of the first connecting wire (211) at the distal end is 0.2 mm to 4 mm.

9. The balloon catheter according to claim 6, characterized in that Along the axial direction of the telescopic section (21), the diameter of the second connecting wire (212) closer to the distal end is smaller than the diameter of the second connecting wire (212) farther from the distal end.

10. The balloon catheter according to claim 9, characterized in that The diameter of the second connecting wire (212) closest to the distal end of the telescopic section (21) is 0.2 mm to 4 mm, and the diameter of the second connecting wire (212) farthest from the distal end of the telescopic section (21) is 0.5 mm to 6 mm.

11. The balloon catheter according to claim 6, characterized in that At a position corresponding to the same mesh (20a), the diameter of the first connecting wire (211) is smaller than or equal to the diameter of the second connecting wire (212).

12. The balloon catheter according to claim 5, characterized in that The balloon catheter further comprises a catheter assembly (30), both ends of the balloon assembly (10) and both ends of the restriction assembly (20) are connected to the catheter assembly (30), and the catheter assembly (30) is used to inflate and deflate the balloon assembly (10).

13. The balloon catheter according to claim 12, characterized in that The proximal connecting section (12) includes a first cone (121) and a first connecting section (122), wherein the first cone (121) is connected between the main section (11) and the first connecting section (122), and the limiting assembly (20) includes a first supporting section (22) and a first fixing section (23), wherein the first supporting section (22) is connected between the first fixing section (23) and the telescopic section (21), and the first supporting section (22) is cone-shaped and corresponds to the first cone (121). The first fixing section (23) is sleeved on the outside of the first connecting section (122) and fixes the first connecting section (122) to the catheter assembly (30); And / or, the distal connecting section (13) includes a second cone (131) and a second connecting section (132), the second cone (131) is connected between the main section (11) and the second connecting section (132), the limiting assembly (20) includes a second supporting section (24) and a second fixing section (25), the second supporting section (24) is connected between the second fixing section (25) and the telescopic section (21), the second supporting section (24) is cone-shaped and corresponds to the second cone (131), the second fixing section (25) is sleeved on the outside of the second connecting section (132), and fixes the second connecting section (132) to the catheter assembly (30).

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